Metodik inom klinisk läkemedelsprövning och biostatistik Catrin Wessman & Michael Ashton

To whom? The course is appropriate for pharmacists, aiming for a professional role in the industry or in the academic world, where it requires an advanced understanding of problem around repeated measurements post-hoc tests and clinical trial methodology. The students obtain an understanding of how the statistical methods (the importance of how one defines the hypothesis choice of analytical method etc) interact with the interpretation of how a drug influences the patients.

Contents 1. The drug development process Clinical phases (“Learn & confirm”) 2. Approvals required 3. Randomized Controlled Trials: Design, randomization, data analysis Parallel vs XO vs factorial and post-hoc tests Repeated measurements Superiority vs non-inferiority Stratification ITT vs PP analyses Endpoints Dimensioning Blinding/placebo

Contents-2 4. Good Clinical Practice 5. The trial protocol and other study documents 6. Adverse Events Classification, reporting 7. Quality Control & Quality Assurance Monitoring, audits, inspection 8. Ethics History, considerations, informed consent

Contents-3 Understanding of the preconditions of different methods by choosing an adequate statistical method when analyzing a given hypothesis 9.parametric or non-parametric methods to handle two or several random samples 10.the principles around post-hoc tests 11.linear regression (both bivariable and multivariable) 12.introduction to repeated measurements

Activities, group exercises Design of FTIM study  PoC study  pivotal confirmatory study The chosen design of each study will be simulated in a virtual study population and the results made available to guide choice of next study Outlining a Clinical Development Plan (CDP) for an antiarrythmic candidate drug. Which clinical studies to conduct for this particular drug under pre-clinical development? What is the optimal chronological sequence of suggested individual studies? Design of a specific clinical study. Writing of its clinical trial protocol. + Application to MPA + Informed Consent Form. (Mandatory participation and presentation) 1 2 3

Activities, exercises Computer exercises (SPSS software) Three practical, hands-on computer sessions on statistical analyses, which the student is expected to carry out independently. The computer sessions are not mandatory, but the student might gain up to 2 points, transferable to the exam. 4

Kursutvärdering: FAB840 VT12

“ I helhet är jag mycket n öjd, och tycker att detta är en kurs som varje akademiker inom naturvetenskapliga inriktningar [inom vilka kliniska studierapporter läses] borde l äs a. I efterhand reflekterar man och t än ker p å hur lite man faktiskt förstod bakgrunden till de artiklar man [tidigare] läst med avseende p å studiedesign och dylikt, och i framtiden kommer man utan tvekan ha en mycket st örre möjlighet att utv är dera artiklar p å ett b ät tre s ät t. ” Ur kursutvärdering: FAB840 VT12

Saxat från kursnämndsprotokollet för Med815, VT16